uring public health crises involving infectious diseases like Ebola or Zika, we sometimes hear people ask, “Why can’t they just make a vaccine or a drug for it?” It’s a great question, with a complex answer.
To start developing a drug or vaccine, you have to understand exactly what causes the disease, and how. With that information in hand, it may be possible to identify potential targets for a treatment. That kind of basic research often takes years. Then add a few more years to develop a prototype.
Next come the preclinical animal studies needed to show the drug or vaccine is safe. It’s also essential to establish a consistent, reproducible, and safe manufacturing process — something that can be made with relative ease on a small scale in a research laboratory is often extremely difficult to make in the large quantities needed for treatment.
These activities are necessary before testing the drug or vaccine in people. That can begin only when the developers, funding agencies, public health experts, patients, and regulatory authorities are in agreement.
The entire process, from basic research to Food and Drug Administration approval, averages about 10 years for drugs and 10 to 15 years for vaccines. A public health crisis doesn’t change the process or let you circumvent any of the steps involved.
One way to speed up drug or vaccine development is to leverage existing products through repurposing. That means using an existing drug or vaccine for a different use than the one it was approved for. Because the drug or vaccine has already been tested for safety and is being manufactured, it can likely be rapidly disseminated.
During the Ebola outbreak in West Africa, which began in 2014, there was keen interest in repurposing already approved drugs to treat people infected with the deadly virus. One example is interferon-beta 1a, an FDA-approved drug for treating multiple sclerosis. It works by modifying the immune system. Because interferon-beta 1a also has antiviral activity, it was tested during the outbreak in a single arm proof-of-concept pilot study to evaluate its safety and effectiveness against Ebola.
At the time of the Zika outbreak, the SEEK Group, a London-based company focused on bringing effective and low-cost treatments to patients in the shortest time possible, was conducting clinical trials in Europe for flu and HIV vaccines. It realized it could employ the same technology underlying these vaccines in one against mosquito-transmitted diseases like Zika. Our company, Halloran Consulting Group, helped SEEK leverage nonclinical and clinical data from its flu and HIV work in order to get its mosquito-borne disease vaccine into clinical trials as quickly as possible.
We also worked with SEEK to develop a scientific approach to expedite vaccine manufacturing so the clinical trial could start sooner.
By using existing research and product development, SEEK was able to leapfrog over many of the early research and development hurdles in the normal vaccine-development scenario. Its anti-Zika vaccine is currently being studied in a Phase 1 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases. While it’s impossible to quantify exactly how much time was saved, an estimate of three to five years of time savings isn’t unreasonable.
When it comes to developing new drugs or vaccines, navigating the regulatory environment can be difficult. Companies must follow myriad regulations, while the FDA staff must oversee many products. To address these bottlenecks during a public health crisis, the FDA takes steps to make it easier to navigate the regulatory environment. It establishes internal working teams dedicated to the mission of developing safe and effective drugs or vaccines as soon as possible and is available around the clock to facilitate development and access to promising ones.
If drug and vaccine development take so long, why aren’t scientists, public health experts, and pharmaceutical companies working on solutions before a public health crisis emerges? Many already are, but with competing priorities for resources, including time, money, and personnel, these efforts are often overlooked or thought to be unimportant when there’s no immediate threat.
Funding tends to arrive after a public health crisis has already begun. This is a time when the key stakeholders — funding agencies, regulators, patient advocacy groups, and the drug or vaccine developer — may have trouble agreeing on the best path forward. In a world of limited resources and competition for attention, prioritization, and funding, the possibility of a problem often doesn’t make the cut for attention and funding, even for really scary diseases like Ebola.
That is human nature. In the absence of new strategies for changing human nature, repurposing represents a promising solution for speeding up drug or vaccine development during public health crises.
Michelle L. Rose is a principal consultant and Claudia K. Fehling is a consultant with Halloran Consulting Group in Boston.